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Most Favored Nation

January 14, 2022 | No Comments
Posted by Frank Ciesla

Over the years I have written about the use of “Most Favored Nation” approach to the pricing of Drugs.

Currently there is a nationwide preliminary injunction enjoining the Department of Health and Human Services from implementing the Most Favored Nation Rule.   Given this preliminary injunction, the Most Favored Nation Model was not implemented on January 1, 2021 and will not be implemented without further rulemaking.  The Trump administration started moving in that direction. It now appears that the Biden administration is rejecting that approach in favor of the government negotiating prices. What is not clear is what standard will be adopted and by whom as to how the approved price will be negotiated. As more details become available, we will comment.

October-December 2021 State Regulatory Developments

January 12, 2022 | No Comments
Posted by Anjali Baxi

Below are the most recent health care related regulatory developments as published in the New Jersey Register from October-December 2021:

  • On October 4, 2021, at 53 N.J.R. 1657(a), the Commissioner released a notice regarding Executive Order No. 103, which declared a Public Health Emergency for the state in response to COVID-19. This notice extends the waiver of the continuing education requirements for current active health officers and REHSs who are renewing their license for the 2022 licensing period. See N.J.A.C. 8:7-1.11, 1.12, 1.13, 1.17.
  • On October 4, 2021, at 53 N.J.R. 1737(a), the Insurance – Department of Banking and Insurance, Individual Health Coverage Program Board, adopted amendments to N.J.A.C. 11:20, Appendix Exhibits A and B. Exhibits can be reviewed by contacting the New Jersey Individual Health Coverage Program. See adopted N.J.A.C. 11:20.
  • On October 4, 2021, at 53 N.J.R. 1738(a), the Insurance – Department of Banking and Insurance, Small Employer Health Benefits Program, adopted amendments to N.J.A.C. 11:21, Appendix exhibits F, G, W, Y, HH, and II. Exhibits can be reviewed by contacting the New Jersey Small Employer Health Benefits Program. See adopted N.J.A.C. 11:21.
  • On October 18, 2021, at 53 N.J.R. 1783(a), the Department of Human Services, Division of Medical Assistance and Health Services adopted new rules regarding nursing facility patient care ratio requirements. This new chapter addresses requirements for defined nursing facilities to report information concerning certain revenues and the use of those revenues for the care of the residents. See adopted N.J.A.C. 10:49A.
  • On October 18, 2021, at 53 N.J.R. 1788(a), the Department of Human Services, Division of Medical Assistance and Health Services readopted a rule regarding chiropractic services. There are also language changes to the chapter. See readopted N.J.A.C. 10:68.
  • On October 18, 2021, at 53 N.J.R. 1791(a), the Department of Human Services, Division of the Deaf and Hard of Hearing, readopted with technical changes a rule regarding the organization of the Division of the Deaf and Hard of Hearing. There are also language changes made to the chapter. See readopted N.J.A.C. 10:150.
  • On October 18, 2021, at 53 N.J.R. 1791(c), the Department of Human Services, Division of Aging Services, Office of the State Health Insurance for the Aged and Disabled, readopted a rule regarding the Senior Gold Prescription Program Manual. See readopted N.J.A.C. 10:167B.
  • On October 18, 2021, at 53 N.J.R. 1792(a), the Department of Human Services, Division of Aging Services, Office of State Health Insurance for the Aged and Disabled, readopted a rule regarding the provision of pharmaceutical services under the Senior Gold Program. See readopted N.J.A.C. 10:167C.
  • On October 18, 2021, at 53 N.J.R. 1808(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Medical Examiners, made administrative changes regarding the Cannabis Regulatory Commission. This includes agency name updates, contact information, and addresses. See adopted N.J.A.C. 13:35-7.

 

  •  On November 1, 2021, at 53 N.J.R. 1838(b), the Department of Health published a notice of readoption of N.J.A.C. 8:45, the regulations establishing clinical laboratory licensure requirements and fees and fees for services performed by the NJDOH Public Health and Environmental Laboratories. Effective September 29, 2021. The Department is developing a rulemaking to extensively revise, update, and reorganize existing N.J.A.C. 8:45, and anticipates filing this rulemaking with the Office of Administrative Law for processing in the ordinary course.
  • On November 1, 2021, at 53 N.J.R. 1840(a), the Department of Human Services, Division of Medical Assistance and Health Services (DMHAS) published a notice of readoption of N.J.A.C. 10:32, addressing advanced directives for mental health care. Effective September 24, 2021. The chapter applies to State psychiatric hospitals and DMHAS services.  DMHAS has identified changes to be made to the rules but are too significant to be made part of this readoption.  The anticipated amendments may include substantial amendments and/or recodifications in part, as may be appropriate, to the chapter to reflect the retention of the State psychiatric hospitals by the Department of Health following the return of the DMHAS to the Department of Human Services in accordance with Reorganization Plan 001-2018. Once the review is completed, a separate rulemaking containing proposed amendments and/or recodifications will be published in the New Jersey Register and a 60-day public comment period will be provided.
  • 53 N.J.R. 1840(a), 53 N.J.R. 1841(a), the Department of Human Services, Division of Medical Assistance and Health Services published a notice of readoption of N.J.A.C. 10:37 (Community Mental Health Services Act) with technical amendments. The technical amendments include changes to update the Division’s current table of organization, as well as the current name of the “Division of Mental Health and Addiction Services” and the Division’s address. The change to the Division’s name reflects the merger of the former Division of Mental Health and the former Division of Addiction Services under the Fiscal Year 2010-2011 State Appropriations Act. Additionally, an outdated reference to N.J.A.C. 10:37-12, Children’s Partial Care Programs, is being removed because that subchapter was recodified within N.J.A.C. 10:191, Children’s Partial Care Programs, by the Department in 2007; and N.J.A.C. 10:191 was subsequently recodified to N.J.A.C. 3A:58 by the Department of Children and Families in 2017. Effective October 4, 2021; Technical Changes:  November 1, 2021.
  • On November 1, 2021, at 53 N.J.R. 1841(b), the Department of Human Services, Division of Medical Assistance and Health Services published a notice of readoption of N.J.A.C. 10:37E (Outpatient Service Standards) with technical amendments. The technical amendments include changes to update the current name of the “Division of Mental Health and Addiction Services” and changes to the Diagnostic and Statistical Manual of Mental Disorders (DSM). The change to the Division’s name reflects the merger of the former Division of Mental Health and the former Division of Addiction Services pursuant to the Fiscal Year 2010-2011 State Appropriations Act. The changes to DSM references include updates to the current DSM criteria by the American Psychiatric Association (APA), including elimination of the multi-axial system of diagnoses, and correcting a reference to the publishing entity of the DSM to the APA. Effective September 24, 2021; Technical Changes November 2, 2021.
  • On November 1, 2021, at 53 N.J.R. 1842(a), the Department of Human Services, Division of Medical Assistance and Health Services published a notice of readoption of N.J.A.C. 10:37F (Partial Care Service Standards) with technical amendments. The technical changes include changes to update the current name of the “Division of Mental Health and Addiction Services” and changes to the Diagnostic and Statistical Manual of Mental Disorders (DSM). The change to the Division’s name reflects the merger of the former Division of Mental Health and the former Division of Addiction Services pursuant to the Fiscal Year 2010-2011 State Appropriations Act. The changes to DSM references include updates to the current DSM edition and criteria by the American Psychiatric Association, including elimination of the multi-axial system of diagnoses. Effective September 24, 2021; Technical Changes November 2, 2021.
  • On November 1, 2021, at 53 N.J.R. 1843(c), the Department of Human Services, Division of Medical Assistance and Health Services published a notice of readoption of N.J.A.C. 10:58 (Nurse Midwifery Services) with technical amendments. The technical changes include: correcting all references to “Department of Health” to reflect the current name of that Department pursuant to P.L. 2012, c. 17; changing all references to “Medicaid/NJ FamilyCare” to reflect the preferred nomenclature of the program; changing references to “Health Maintenance Organization” to “Managed Care Organization”; correcting contact information for the DMAHS fiscal agent; and changing references to “Health Care Financing Administration” to “Centers for Medicare and Medicaid Services” to reflect the current name of the Federal agency. Effective September 24, 2021; Technical Changes November 2, 2021.
  • On November 1, 2021, at 53 N.J.R. 1846(a), the Department of Human Services, Division of Medical Assistance and Health Services published a notice of readoption of New Jersey Care … Special Medicaid Programs Manual. The Manual extends Medicaid eligibility to certain persons not eligible under the provisions at N.J.A.C. 10:69, AFDC-Related Medicaid, or 10:71, Medicaid Only. Effective September 28, 2028. The Department is preparing a notice of proposal with substantive amendments to this chapter to be published following this readoption, which is intended to prevent the chapter from expiring.
  • On November 1, 2021, at 53 N.J.R. 1852(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Psychological Examiners adopted an amendment of N.J.A.C. 13:42-8.1, regarding Client records: Confidentiality. The amendment requires that a licensee retain the permanent client record for at least 7 years from the date of last entry, unless otherwise provided by law. Records for minors must be kept for seven years from the date of last entry or until the client turns 25 years old, whichever is longer, unless otherwise provided by law.
  • On November 1, 2021, at 53 N.J.R. 1866(a), the Department of Health issued a public notice of receipt of petition for rule change to N.J.A.C. 8:39-43.10, approval of a nurse aid in long term care (LTC) facility training program and eligibility criteria for instructor/evaluators in training programs for LTC facility nurse aids. This would alleviate some difficulty in finding instructors for the training programs.
  • On November 1, 2021, at 53 N.J.R. 1868(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Marriage and Family Therapists issue a public notice of receipt of petition for rulemaking that requests an amendment to N.J.A.C. 13:34-5.3 to change the name “American Association for Marriage and Family Therapy of New Jersey Inc., (AAMFT-NJ)” to the “New Jersey Association for Marriage and Family Therapy (NJAMFT). This name change was recommended to accurately identify the entity that can approve CE courses and programs.
  • On November 15, 2021, at 53 N.J.R. 1920(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board Chiropractic Examiners published a notice of readoption of N.J.A.C. 13:44E. Effective October 19, 2021.
  • On November 15, 2021, at 53 N.J.R. 1935(a), the Department of Health published a notice for rulemaking requesting certain amendments to N.J.A.C. 8:43G-1.2, Definitions and 4.1, Patient Rights. Specifically, the request is to amend the term “next of kin” and identify a hierarchy of individuals whom a hospital could contact to provide consent for a patient when the patient is unable to consent, has no next of kin, and has not designated an individual to make health care decisions on the patient’s behalf.

 

  •  On December 6, 2021, at 53 N.J.R. 1982(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Medical Examiners issued a proposal for a new rule at N.J.A.C. 13:35-6.20A for radiologist assistants performing procedures. The rules include definitions for various levels of supervision and permitted tasks within the scope of the license.
  • On December 6, 2021, at 53 N.J.R. 2008(a), the Department of Health issued a notice of readoption of Licensure Standards for Mental Health Programs with technical changes and recodification of N.J.A.C. 10:101 as N.J.A.C. 8:121. Effective Date:  October 20, 2021; Technical Changes December 6, 2021. The Department is making technical changes throughout N.J.A.C. 8:121 to update references throughout the chapter to the Department of Health licensing authority.
  • On December 6, 2021, at 53 N.J.R. 2013(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Medical Examiners adopted amendments, adopted a new rule and repealed a rule related to Surgery, Special Procedures, Anesthesia Services Performed in an Office Setting. The new rule permit APNs, midwives and PAs to perform abortion procedures to expand abortion access.  See amended N.J.A.C. 13:35-4A.1-4A.12, adopted new rule N.J.A.C. 13:35-4A.19; repealed N.J.A.C. 13:35-4.2. Effective December 6, 2021.
  • On December 6, 2021, at 53 N.J.R. 2050(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Respiratory Care adopted new rules regarding telehealth and telemedicine at N.J.A.C. 13:44F-11. Effective December 6, 2021.
  • On December 20, 2021, at 53 N.J.R. 2132(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Marriage and Family Therapy proposed to delete N.J.A.C. 13:34-2.2(a)6 to remove the requirement to submit a written plan of supervision as a precondition for licensure as an associate marriage and family therapist. In addition, the Board proposed to add N.J.A.C. 13:34-3.3(k) to specify that it is the responsibility of a qualified supervisor to create a written plan of supervision. In accordance with N.J.S.A. 45:8B-18.2, the proposed amendments to N.J.A.C. 13:34-2.2 and new 3.3(l), specify that the written plan for supervision of the licensed associate marriage and family therapist must be approved by the Board prior to the performance of counseling by the licensed associate marriage and family therapist. There was a 60 day comment period for the proposed rule.
  • On December 20, 2021, at 53 N.J.R. 2198(a) the Department of Health, Certificate of Need and Licensing Division, CN & Healthcare Facility Licensure Program readopted with technical amendments, N.J.A.C. 8:33C, the Rules for Regionalized Perinatal Services and Maternal and Child Health Consortia. Effective November 18, 2021, Technical changes December 20, 2021.
  • On December 20, 2021, at 53 N.J.R. 2199(a), the Department of Health, Certificate of Need and Licensing Division, CN & Healthcare Facility Licensure Program readopted with technical amendments to N.J.A.C. 8:39, Standards for the Licensure of Long Term Care Facilities. Effective November 18, 2021, Technical changes December 20, 2021. The technical amendments include changes to Department’s name and contact information and references to the change in name and contact information of the State Long Term Care Ombudsman’s Office.
  • On December 20, 2021, at 53 N.J.R. 2204(a), the Department of Health, Certificate of Need and Licensing Division, CN & Healthcare Facility Licensure Program readopted with technical amendments to N.J.A.C. 8:43F, Standards for Licensure of Adult Day Health Services Facilities. Effective November 18, 2021, Technical changes December 20, 2021.  The technical amendments include changes to the name of the Department/Division throughout the rules.
  • On December 20, 2021, at 53 N.J.R. 2208(a), the Department of Health, Certificate of Need and Licensing Division, published a final rule readopting the Standards for Licensure of Residential Substance Use Disorder Treatment (at N.J.A.C. 10:161A) as N.J.A.C. 8:111. This recodification of the standards from the Department of Human Services Chapter to the Department of Health Chapter is in furtherance of the reorganization of services under each Department.  Effective November 10, 2021, Technical changes December 20, 2021.
  • On December 20, 2021, at 53 N.J.R. 2222(a), the Department of Human Services, Division of Medical Assistance and Health Services, published a final rule readopting N.J.A.C. 10:64 (Hearing Aid Services) with technical changes relating to references to Medicaid/NJ FamilyCare and Gainwell Technologies (formerly UNISYS). Effective November 16, 2021, Technical changes December 20, 2021.
  • On December 20, 2021, at 53 N.J.R. 2224(a), the Department of Human Services, Division of Medical Assistance and Health Services, published a final rule readopting N.J.A.C. 10:67 (Psychological Services) with technical changes related to agency name and contact information nchanges. The chapter contains rules for related to the provision of psychological services to Medicaid/NJ FamilyCare beneficiaries by psychologists in private practice who are reimbursed on a fee-for-service basis but not for psychologists employed by the State, county or private psychiatric hospitals, independent clinics, or those psychologists who are employed by residential treatment centers under contract with a State agency.
  • On December 20, 2021, at 53 N.J.R. 2229(b), the Ophthalmic Dispensers and Ophthalmic Technicians adopted new final rules, amendments and repeals of rules in N.J.A.C. 8:33. The rules relate to the application for apprentice certificates, out of state dispenser applications, and reporting of unlawful conduct.  Effective December 20, 2021.

 Special thanks to Jessica Warwick, Law Student Intern

 

September 2021 State Regulatory Developments

October 12, 2021 | No Comments
Posted by Anjali Baxi


Below are the most recent health care related regulatory developments as published in the New Jersey Register in September 2021:

  • On September 7, 2021, at 53 N.J.R. 1418(a), the Office of the Governor released Executive Order No. 252 directing vaccination or testing requirements for workers in health care facilities and high-risk settings. Health care and high-risk congregate settings must retain a policy that requires its workers to provide proof of full COVID-19 vaccination or complete COVID-19 testing one to two times per week. The order addresses what documents may be presented to show proof of vaccination. Additionally, it lists what specific settings and workers are deemed “covered.” See Exec. Order. No. 252.
  • On September 7, 2021, at 53 N.J.R. 1440(a), the Department of Health, Public Health Services Branch, Division of HIV, STD, and TB Services, proposed recodification, amendments, new rules, and repeals. The amendments address spelling and language changes, as well as definitional changes and additions. The new rules would add web-based publications that the Department uses for reference. See proposed N.J.A.C. 8:57-2.1, 2.3, 2.11. See proposed N.J.A.C. 8:65-1.2, 1.4, 2, 3.1, 3.3. See proposed N.J.A.C. 8:57-2.2, 2.4 through 2.10, 2.12.
  • On September 7, 2021, at 53 N.J.R. 1451(a), the Department of Human Services, Division of Medical Assistance and Health Services, proposed the readoption of the Transportation Services Manual with amendments. See proposed N.J.A.C. 10:50, as well as, proposed repeal of certain sections of the chapter. See proposed N.J.A.C. 10:50-1.8, 1.10, 1.11, 1.12, 1.13.
  • On September 7, 2021, at 53 N.J.R. 1490(a), the Commission of the Department of Human Services readopted the Rules of Practice; Petition for Rulemaking, with technical changes. See N.J.A.C. 10:1.
  • On September 7, 2021, at 53 N.J.R. 1491(a), the Department of Human Services, Office of Licensing readopted the Standards for Private Licensed Facilities for Persons with Developmental Disabilities. See N.J.A.C. 10:47.
  • On September 7, 2021, at 53 N.J.R. 1491(b), the Department of Human Services, Division of Medical Assistance and Health Services readopted Psychiatric Adult Acute Partial Hospital and Partial Hospital Services. See N.J.A.C. 10:52A.
  • On September 7, 2021, at N.J.R. 1492(a), the Department of Human Services, Division of Medical Assistance and Health Services readopted Case Management Services with technical changes. See N.J.A.C. 10:73.
  • On September 7, 2021 at 53 N.J.R. 1499(a), the Department of Labor and Workforce Development, Division of Wage and Hour Compliance readopted the Notification Concerning Health Benefits Plans. See N.J.A.C. 12:63.
  • On September 7, 2021, at 53 N.J.R. 1500(a), the Department of Labor and Workforce Development, Division of Workers’ Compensation readopted the Rules of the Division of Workers’ Compensation. See N.J.A.C. 12:235.
  • On September 7, 2021, at 53 N.J.R. 1500(b), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Physical Therapy Examiners readopted the Rules of the State Board of Physical Examiners with amendments. See N.J.A.C. 13:39A. Additionally, repeals and new rules were adopted. See N.J.A.C. 13:39A-5.5, 5A and N.J.A.C. 13:39A-4.3, 5.2A.
  • On September 7, 2021, the Department of Labor and Workforce Development, Public Safety and Occupational Safety and Health adopted a special amendment to protect healthcare workers from occupational exposure to COVID-19 in settings where people with COVID-19 are expected to be. Healthcare employers must implement plans to control COVID-19 hazards and reduce transmission in the workplace, along with other rules regarding COVID-19 in the healthcare workplace. See adopted N.J.A.C 12:100-4.2.
  • On September 20, 2021, at 53 N.J.R. 1558(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Medical Examiners, Electrologists Advisory Committee proposed amendments, repeal, and new rules. These changes include definitional updates, reference changes and removal, as well as relocating the renewal and reinstatement provisions that relate to an office premise license. See proposed N.J.A.C. 13:35-12.1, 12.2, 12.6 through 12.13, 12.15, 12.19. See proposed repeal N.J.A.C. 13:35-12:14. See proposed N.J.A.C. 13:35-12.10A, 12.14A, 12.14B.
  • On September 20, 2021, at 53 N.J.R. 1562(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Pharmacy proposed a new rule that will require every pharmacy permit holder to implement a continuous quality improvement program to address prescription errors. See proposed N.J.A.C. 13:39-1.9.
  • On September 20, 2021, at 53 N.J.R. 1570(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Psychological Examiners adopted amendments, new rules, and repeals that revise the standard for denying a license based on conduct constituting a crime or offense. See adopted N.J.A.C. 13:42-5.3, 10.17, 9.3, 10.4, 10.18, 11.4, 10.18.
  • On September 20, 2021, at 53 N.J.R. 1580(a), the Department of Treasury, Cannabis Regulatory Commission, recodified the Department of Health’s rules to account for the creation of the Cannabis Regulatory Commission. See recodification of N.J.A.C. 8:64 as 17:30A.

 

Special thanks to Jessica Warwick, Law Student Intern

 

August 2021 State Regulatory Developments

September 7, 2021 | No Comments
Posted by Anjali Baxi

Below are the most recent health care related regulatory developments as published in the New Jersey Register in August 2021:

  • On August 2, 2021, at 53 N.J.R. 1278(a), the Department of Human Services, Division of Medical Assistance and Health Services, readopted the Manual for Dental Services. See adopted N.J.A.C. 10:56.
  •  On August 2, 2021, at 53 N.J.R. 1278(b), the Department of Human Services, Division of Medical Assistance and Health Services, readopted the Medical Supplier Manual. Additionally, technical changes were made to reflect the current name for the “Department of Health” and “Medicaid/NJ FamilyCare.” See adopted N.J.A.C. 10:59.
  •  On August 2, 2021, at 53 N.J.R. 1279(a), the Department of Human Services, Division of Medical Assistance and Health Services, readopted Independent Clinical Laboratories. Additionally, technical changes were made to reflect the name of the current Division of Medical Assistance and Health Services fiscal agent. See adopted N.J.A.C 10:61.
  •  On August 2, 2021, at 53 N.J.R. 1279(b), the Department of Human Services, Division of Medical Assistance and Health Services, readopted the Medically Needy Program. See adopted N.J.A.C. 10:70.
  •  On August 2, 2021, at 53 N.J.R. 1280(a), the Department of Human Services, Division of Medical Assistance and Health Services, readopted NJ Family Care. See adopted N.J.A.C. 10:78.
  •  On August 2, 2021, at 53 N.J.R. 1280(b), the Department of Human Services, Division of Aging Services, Office of Area Agency on Aging Administration, readopted Adult Day Services Program for Persons with Alzheimer’s Disease or Related Disorders. See adopted N.J.A.C. 10:164A
  •  On August 2, 2021, at 53 N.J.R. 1283(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Marriage and Family Therapy Examiners, adopted new rules regarding telemedicine and telehealth, authorizing healthcare providers to engage in telemedicine and telehealth. Additionally, this adoption includes new rules to be followed when engaging in telemedicine and telehealth. See adopted N.J.A.C. 13:34-6A.
  •  On August 2, 2021, at 53 N.J.R. 1285(a), The Department of Law and Public Safety, Division of Consumer Affairs, State Board of Marriage and Family Examiners, Professional Counselor Committee, adopted new rules regarding telemedicine and telehealth, authorizing healthcare providers to engage in telemedicine and telehealth. Additionally, this adoption includes new rules to be followed when engaging in telemedicine and telehealth. See adopted N.J.A.C. 13:34-32.
  •  On August 2, 2021, at 53 N.J.R. 1288(a), The Department of Law and Public Safety, Division of Consumer Affairs, State Board of Medical Examiners, Physician Assistants Advisory Committee, adopted new rules regarding telemedicine and telehealth, authorizing healthcare providers to engage in telemedicine and telehealth. Additionally, this adoption included new rules to be followed when engaging in telemedicine and telehealth. See adopted N.J.A.C. 13:35-2B.3.
  •  On August 2, 2021, at 53 N.J.R. 1290(a), The Department of Law and Public Safety, Division of Consumer Affairs, State Board of Medical Examiners, Electrologists Advisory Committee, adopted new rules regarding telemedicine and telehealth, authorizing healthcare providers to engage in telemedicine and telehealth. Additionally, this adoption included new rules to be followed when engaging in telemedicine and telehealth. See adopted N.J.A.C. 13:35-12A.
  •  On August 16, 2021, at 53 N.J.R. 1327(a), the Department of Human Services, Division of Medical Assistance and Health Services, proposed readoption and amendments to the Home Care Services chapter. The proposed amendments include definition changes, as well as new rules. These new rules address new billing and payment guidelines. See proposed N.J.A.C. 10:60.
  •  On August 16, 2021, at 53 N.J.R. 1378(b), The Department of Health, Health Systems Branch, Divisions of Certificate of Need and Licensing, Certificate of Need and Healthcare Facility Licensure Program, adopted new rules addressing the registration standards for Telemedicine and Telehealth Organizations. See adopted N.J.A.C. 8:53.
  •  On August 16, 2021, at 53 N.J.R. 1404(c), the Department of Health, Office of the Commissioner released a notice of grant availability. See https://healthapps.state.nj.us/noticeofgrant/noticegrants.aspx
  •  On August 16, 2021, at 53 N.J.R. 1405(c), the Department of Law and Public Safety, Division of Consumer Affairs, released a notice addressing that the State Board of Marriage and Family Therapy Examiners received a petition for rulemaking from the New Jersey Association of Marriage and Family Therapy Legislative Committee. Petitioner requests that the requirement that a plan of supervision be submitted as part of the application for licensure as an associate marriage and family therapist be eliminated from the Code. See N.J.A.C. 13:34-2.2.

 

Special thanks to Jessica Warwick, Law Student Intern

June-July 2021 State Regulatory Developments

August 11, 2021 | No Comments
Posted by Anjali Baxi

Below are the most recent health care related regulatory developments as published in the New Jersey Register in June and July 2021:

  • On June 7, 2021, at 53 N.J.R. 975(a), the Health Commissioner, released a notice in regards to Executive Order No. 103. This notice addresses the renewal of certified nurse aide certifications. If a CANs certification is set to expire between March 1, 2021 and the end of the Public Health Emergency, shall be permitted to renew their certification until 30 days after the end of the Public Health Emergency. See N.J.A.C. 8:39-43.4, 43.6.

 

  • On June 7, 2021, at 53 N.J.R. 1001(a), the Department of Human Services, Division of Mental Health and Addiction Services, adopted new organizational rules in order to better inform the public about what the Division of Mental Health and Addiction does. These new rules improve readability, as well as reflect the retention of the State Psychiatric hospitals. See adopted N.J.A.C. 10:30

 

  •  On June 7, 2021, at 53 N.J.R. 1001(b), the Department of Human Services, Division of Medical Assistance and Health Services, adopted amendments addressing podiatry services. Whereas podiatry services are optional in accordance with federal Medicaid laws, New Jersey has decided to provide podiatry services. See adopted N.J.A.C. 10:57.

 

  • On June 7, 2021, at 53 N.J.R. 1027(a), the Department of Law and Public Safety, Division of Consumer Affairs, released a notice that a petition has been filed addressing a plan of supervision that is currently required as part of the application to be a licensed marriage and family therapist. See N.J.A.C. 13:34-2.2

 

  • On June 21, 2021, at 53 N.J.R. 1041(a), the Office of the Governor, released an executive order extending the Public Health Emergency. See Exec. Order No 240.

 

  • On June 21, 2021, at 53 N.J.R. 1047(a), the Office of the Governor released an executive order that rescinds the requirements of Executive order No. 107. Non-profits no longer have to accommodate telework to the maximum extent possible. See Exec. Order No. 243.

 

  • On July 6, 2021, at 53 N.J.R. 1131(a), the Office of the Governor released an executive order that ended the COVID-19 Public Health Emergency. However, the State of Emergency remains. See Exec Order No. 244.

 

  • On July 6, 2021, at 53 N.J.R. 1145(b), the Department of Human Services, Division of Developmental Disabilities, adopted a rule addressing the family maintenance standard, medical cost standard, tuition deduction, and the cost of care and maintenance rates for individuals residentially placed by the Division of Developmental Disabilities. See N.J.A.C. 10:46D-3.2.

Special thanks to Jessica Warwick, Summer Associate

April 2021 State Regulatory Developments

July 7, 2021 | No Comments
Posted by Anjali Baxi

Below are the most recent health care related regulatory developments as published in the New Jersey Register in April 2021:

  •  On April 5, 2021 at 53 N.J.R 459(a), the Commissioner of Health modified rule N.J.A.C 8:33E-1.4 and -2.3 pursuant to executive order 103, concerning the minimum volume utilization requirements for invasive cardiac diagnostic facilities, cardiac surgical centers, and physicians practicing at those facilities. Some facilities were unable to meet their volume requirements because of the reduced number of elective procedures as a result of COVID-19. According to this rule:
    • The minimum volume utilization requirement for facilities outlined in N.J.A.C 8:33E-1.4 and -2.3 are waived for the duration of the Public Health Emergency, as long as one quarter of the facility’s reporting cycle is covered by the Public Health Emergency; and
    • Physician volume utilization requirements are waived for any calendar year that the Public Health Emergency was in effect for 90 days or more.

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May 2021 State Regulatory Developments

July 7, 2021 | No Comments
Posted by Anjali Baxi

Below are the most recent health care related regulatory developments as published in the New Jersey Register in May 2021:

  •  On May 3, 2021, at 53 N.J.R. 677(a), the Department of Banking and Insurance, Small Employer Health Program proposed an amendment regarding small employer health benefit plans. This includes language that should be changed to comply with several Public Laws. See proposed N.J.A.C. 11:21.

 

  •  On May 3, 2021, at 53 N.J.R. 680(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Pharmacy, proposed an amendment that will allow pharmacy interns and externs, under direct supervision of a pharmacist, to administer vaccinations. See proposed N.J.A.C 13:39-4.21.

 

  • On May 3, 2021, at 53 N.J.R. 700(b), the Health Department, Division of Certificate of Need and Licensing, Certificate of Need and Healthcare Facility Licensure Program, adopted several amendments and a new rule addressing hospice licensing standards and patient care services. This includes changes to the language of definitions and new guidelines for acceptance and disposal of prescription medication. See adopted N.J.A.C 8:42C-6.4. See adopted N.J.A.C. 8:42C-1.2, 2.1, 2.5, 2.7, 3.1, 3.2, 3.3, 3.5, 10.2, 10.7, 11.8.

 

  • On May 3, 2021 at 53 N.J.R. 703(a), the Department of Health, Health Systems Branch, Division of Certificate of Need and Licensing, repealed and adopted a new rule, as well as adopted several amendments. Definitional changes, licensure procedure changes, and other requirement changes were made to the Manual of Standards for Licensing of Ambulatory Care Facilities. Several changes were made to the Hospital Licensing Standards. A new form was added for the Acute Stroke Registry, which can be found at http://www.nj.gov/health/forms. See adopted N.J.A.C 8:43G-7A. See adopted N.J.A.C 8:43A-1.3, 2.2 2.3, 2.4, 2.5, 2.8, 2.9, 3.3, 3.4, 3.6, 3.7, 12.7, 16.3, 23.3, 28.3, 28.7, 29.1, 30.7, 30.10, 33.1, 33.4. See adopted N.J.A.C. 8:43G-2.13, 5.16, 7.23, 7.28, 7A.6, 12.12, 15.1, 16.1, 23.6, 28.19, 28.24, 32.23.

 

  • On May 3, 2021, at 53 N.J.R. 717(a), the Department of Human Services, Division of Disability Services, provided an updated Consumer Cost Share Obligation Table for 2021. See adopted N.J.A.C. 10:140-4.3.

 

  • On May 17, 2021, at 53 N.J.R. 761(a), the Governor extended the Public Health Emergency. See Exec. Order No 235.

 

  • On May 17, 2021, at 53 N.J.R. 936(b), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Nursing, adopted new amendments and new rules addressing the Nurse Licensure Compact. See adopted N.J.A.C 13:37-2.1, 2.2, 2.3, 7.1, 9.3. See adopted N.J.A.C 13:37-2.4, 8.4.

 

  • On May 17, 2021, at 53 N.J.R. 937(a), the Department of Law and Public Safety, Divisions of Consumer Affairs, New Jersey Board of Nursing, adopted amendments addressing continuing education and educational requirements for certification of advanced practice nurses. See adopted N.J.A.C 13:37-5.3, 7.2.

 

  • On May 17, 2021, at 53 N.J.R. 953(a), the Department of Health released a public notice cancelling the certificate of need call for more long-term care beds for severe behavior management, which was originally in accordance with N.J.A.C. 8:33-4.1(a) and N.J.S.A. 26:2H-1.

 

Special thanks to Jessica Warwick, Summer Associate

February 2021-March 2021 State Regulatory Report

March 16, 2021 | No Comments
Posted by Anjali Baxi

Below are the most recent health care related regulatory developments as published in the New Jersey Register in February and March 2021:

  • On February 16, 2021 at 53 N.J.R. 195(a), the Commissioner of Health adopted a temporary rule waiver/modification of the requirements governing the expiration and renewal of certificates for Certified Medication Aides (CMAs) at N.J.A.C. 8:36-9.2. Section 6 of EO 103 that modifies the expiration dates and recertification requirements for CMAs as follows:
    1. CMA certifications that expire between March 1, 2020 and December 31, 2020, are automatically extended until March 19, 2021; and
    2. Any CMA whose certification expires between March 1, 2020 and December 31, 2020, are permitted to renew his or her certification outside of the two-year renewal window, up to and including March 19, 2021; and
    3. CMAs with certifications expiring between March 1, 2020 and December 31, 2020, are permitted to complete CEUs required for recertification up to March 19, 2021.

After March 19, 2021, all CMAs will be required to comply with all regular recertification requirements set forth in N.J.A.C. 8:36-9.2 (b) and (d).

  • On February 16, 2021 at 53 N.J.R. 273(a), the Department of Health, in compliance with N.J.S.A. 52:14-34.4 et seq. (P.L. 1987, c. 7), the Department of Health published notice of grant availability, subject to fund availability, in the Department of Health Directory of Grant Programs. This publication may be viewed through the Internet at: http://healthapps.state.nj.us/noticeofgrant/noticegrants.aspx.

 

  • On March 1, 2021, at 53 N.J.R. 366(a) the Department of Law and Public Safety, Division of Consumer Affairs, Board of Medical Examiners adopted amendments to rules that permit all licensed midwives to administer, or facilitate the administration of, nitrous oxide for pain relief in health care facilities licensed by the Department of Health. See N.J.A.C. 13:35-2A.10 and 2A.12.

 

  • On March 15, 2021, at 53 N.J.R. 406(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Dentistry proposed a new subchapter addressing telemedicine and telehealth regulations. See proposed N.J.A.C. 13:30-9.

 

  • On March 15, 2021, at 53 N.J.R. 410(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Marriage and Family Therapy Examiners, Alcohol and Drug Counselor Committee, proposed a new subchapter addressing telemedicine and telehealth regulations.  See proposed N.J.A.C. 13:34C-7.

 

  • On March 15, 2021, at 53 N.J.R. 414(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Respiratory Care, proposed a new subchapter addressing telemedicine and telehealth regulations. See proposed N.J.A.C. 13:44F-11

 

  • On March 15, 2021, at 53 N.J.R. 417(a), the Department of Law and Public Safety, Division of Consumer Affairs, Occupation Therapy Advisory Council, proposed a new subchapter addressing telemedicine and telehealth regulations. See proposed N.J.A.C N.J.A.C. 13:44K-7.

 

  • On March 15, 2021, at 53 N.J.R. 427(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Veterinary Medical Examiners adopted new telemedicine and telehealth regulations. The commentary discusses at length that, veterinarians are healthcare providers that provide health care services to animals and are subject to the telemedicine statute.  See N.J.A.C. 13:44-4A.

 

  • On March 15, 2021, at 53 N.J.R. 435(a), the Department of Health published a notice postponing the certificate of need call for applications for new specialized long-term beds for pediatric care in accordance with the provisions of N.J.A.C. 8:33H-1.5 and N.J.S.A. 26:2H-1 et seq.

 

  • On March 15, 2021, at 53 N.J.R. 435(b), the Department of Health published a notice postponing certificate of need call for applications for new specialized long-term beds for severe behavior management in accordance with the provisions of N.J.A.C. 8:33H-1.6 and N.J.S.A. 26:2H-1 et seq.

 

  • On March 15, 2021, at 53 N.J.R. 435(c), the Department of Health published a notice postponing the certificate of need call for applications for new specialized long-term beds for ventilator care in accordance with the provisions of N.J.A.C. 8:33H-1.6 and N.J.S.A. 26:2H-1 et seq.

 

 

New Policy to Remove Barriers to COVID-19 Testing

March 3, 2021 | No Comments
Posted by Anjali Baxi

On February 26, 2021, the Centers for Medicare & Medicaid Services, Department of Labor and Department of Treasury issued guidance removing barriers to COVID-19 diagnostic testing and vaccinations and strengthening requirements that plans and issuers cover diagnostic testing without cost sharing. This guidance makes clear that private group health plans and issuers generally cannot use medical screening criteria to deny coverage for COVID-19 diagnostic tests for individuals with health coverage who are asymptomatic, and who have no known or suspected exposure to COVID-19. Such testing must be covered without cost sharing, prior authorization, or other medical management requirements imposed by the plan or issuer. For example, covered individuals wanting to ensure they are COVID-19 negative prior to visiting a family member would be able to be tested without paying cost sharing.  The guidance also includes information for providers on how to get reimbursed for COVID-19 diagnostic testing or for administering the COVID-19 vaccine to those who are uninsured.  Click here for the newly issued guidance.  See press release here.

The new guidance should encourage providers to offer COVID-19 testing at their offices and outpatient locations since private group health plans and issuers must cover and reimburse for COVID-19 testing of asymptomatic individuals and defers to the provider’s individual clinical assessment of the patient to determine whether the patient should be tested for COVID-19.  This new guidance should also increase patient access to testing and remove barriers to encourage patients to be tested prior to travel without fears of large out of pocket payment for testing.  The provider should check with health plans to confirm that they have implemented this policy prior to starting to administer the test to the newly covered group.  Likewise, patients should check their coverage under their health plans.

December 2020/January 2021 State Regulatory Report

March 3, 2021 | No Comments
Posted by Anjali Baxi

Below are the most recent health care related regulatory developments as published in the New Jersey Register in December 2020 and January 2021:

  • On December 7, 2020, at 52 N.J.R. 2144(a), the Department of Health published a public notice postponing certificate of need call for applications for additional pediatric intensive care beds in accordance with the provisions of N.J.A.C. 8:33 and N.J.S.A. 26:2H-1 et seq., scheduled for September 1, 2020, until September 1, 2021.

 

  • On January 4, 2021, at 53 N.J.R. 12(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Medical Examiners, proposed to repeal N.J.A.C. 13:35-4.2 (Rule 4.2), which regulates abortions, and to amend N.J.A.C. 13:35-4A (Rule 4A) to remove barriers to abortion care that are unrelated to safety and to ensure abortions are regulated like other office-based surgical and special procedures. This includes proposing advanced practice clinicians (APCs)-namely, advanced practice nurses (APNs), physician assistants (PAs), certified nurse midwives (CNMs), and certified midwives (CMs)-be permitted to perform certain abortions. Proposed Amendments:  J.A.C. 13:35-4A.1 through 4A.12; Proposed New Rule: N.J.A.C. 13:35-4A.19; Proposed Repeal: N.J.A.C. 13:35-4.2.  Comments Due: March 5, 2021.

 

  • On January 4, 2021, at 53 N.J.R. 81(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Psychological Examiners adopted an amendment to N.J.A.C. 13:42-2.4 regarding degrees earned outside of the United States. It requires individuals who apply for licensure to provide the Board with comprehensive evaluation of their degree performed by the National Register of Health Service Psychologists or a foreign credential evaluation service that is member of the National Association of Credential Evaluation Services (NACES). See N.J.A.C. 13:42-2.4.

 

  • On January 4, 2021, at 53 N.J.R. 86(a), the Department of Health published the anticipated schedule for receipt of certificate of need applications subject to full review procedures for the period beginning January 1, 2021.

 

Category

Deadline for Submission

Long-term care, specialized ventilator

1/2/21 and annually thereafter

Long-term care, specialized behavior modification

1/2/21 and annually thereafter

Long-term care, pediatric

1/2/21 and annually thereafter

Maternal and child health

1/2/21 and annually thereafter

Pediatric intensive care

9/1/21 and annually thereafter

Psychiatric beds

2/1/21 and every two years thereafter

Rehabilitation beds

3/1/21 and every two years thereafter

Children’s hospital

4/1/22 and every three years thereafter

Transplantation

4/1/22 and every three years thereafter

Mobile intensive care unit

6/1/22 and every three years thereafter

Trauma

6/1/22 and every three years thereafter

Long-term care, general

7/1/22 and every three years thereafter

Home health

7/1/22 and every three years thereafter

Burn center, program, unit

4/1/21 and every five years thereafter

New general hospital

4/1/21 and every five years thereafter

 

  • On January 19, 2021, at 53 N.J.R. 101(a), the Department of Health published a notice of emergency adoption of a temporary rule waiver/modification of the requirements governing the expiration and renewal of certifications for Certified Nurse Aides (CNAs) under N.J.A.C. 8:39-43.4 and N.J.A.C. 8:39-43.6. Pursuant to this temporary rule waiver/modification, the expiration date of any nurse aide certification scheduled to expire between March 1, 2020 and December 31, 2020 shall be extended until March 19, 2021. Additionally, any certified nurse aide whose certification is scheduled to expire between March 1, 2020 and December 31, 2020 shall be permitted to renew his or certification outside of the two-year renewal window, up to and until March 19, 2021. After March 19, 2021, all CNAs will be required to resume complying with all regular certification requirements set forth in N.J.A.C. 8:39-43.4 and N.J.A.C. 8:39-43.6. Effective September 1, 2020 to March 19, 2021.

 

  • On January 19, 2021, at 53 N.J.R. 101(b), the Department of Health published a notice of emergency adoption of a temporary rule waiver/modification of the requirement that ambulatory care facilities with licensed mobile vans submit to the Department a service schedule, which includes, but is not limited to, dates, times and address(es) where the licensed mobile van will be temporarily stationed to provide licensed care, or memorandums of understanding between a licensed mobile van and host location. Ambulatory care facilities operating mobile vans may implement the terms of this waiver as necessary until the conclusion of the Public Health Emergency declared by Governor Philip D. Murphy in Executive Order No. 103. See N.J.A.C. 8:43A-23.3 (c).

 

  • On January 19, 2021, at 53 N.J.R. 102 (a), the Department of Health published a notice of emergency adoption of a temporary rule waiver/modification of N.J.A.C. 8:43I-2.9(c), which sets the criminal background clearance requirements for individuals seeking certification or recertification as a nurse aide. The Department, through this rule modification, is providing an additional extension of the expiration date of criminal background clearance notifications issued to CNAs and CNA candidates to ensure that there is adequate staffing of CNAs in good-standing at long term care facilities throughout the State. Accordingly, the Department is extending the expiration dates of criminal background clearance notifications issued to CNAs and CNA candidates between November 1, 2019 and June 30, 2020 until March 19, 2021. If full certification is not obtained by March 19, 2021, the notice shall expire, and a new criminal history report must be obtained. See N.J.A.C. 8:43I-2.9

 

  • On January 19, 2021, at 53 N.J.R. 107(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Dentistry proposed an amendment to N.J.A.C. 13:30-8.18 to require prescribers to co-prescribe an opioid antidote (for example, naloxone) under certain circumstances. In addition, the Board proposes to amend N.J.A.C. 13:30-8.18 to implement P.L. 2017, c. 341, amending N.J.S.A. 24:21-15.2, which concerns limitations on prescribing, administering, or dispensing of controlled dangerous substances, with specific limitations for opioid drugs, and establishes special requirements for the management of acute and chronic pain. The revised law and proposed amendments clarify the timing of the requirement to enter into a pain management agreement, amend the definition of “initial prescription,” and revise the definition of “chronic pain” consistent with the amended statute. Proposed Amendment N.J.A.C. 13:30-8.18.

 

  • On January 19, 2021, at 53 N.J.R. 109(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Nursing proposed to amend N.J.A.C. 13:37-7.9A to require prescribers to co-prescribe an opioid antidote (for example, naloxone) under certain circumstances. In addition, the Board proposes to amend N.J.A.C. 13:37-7.9A to implement P.L. 2017, c. 341, amending N.J.S.A. 24:21-15.2, which concerns limitations on prescribing, administering, or dispensing of controlled dangerous substances, with specific limitations for opioid drugs, and establishes special requirements for the management of acute and chronic pain. These limitations and requirements apply to certified advanced practice nurses. The revised law and proposed amendments clarify the timing of the requirement to enter into a pain management agreement, amend the definition of “initial prescription,” and revise the definition of “chronic pain” consistent with the amended statute. Proposed Amendment: N.J.A.C. 13:37-7.9A

 

  • On January 19, 2021, at 53 N.J.R. 112(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Optometrists proposed to amend N.J.A.C. 13:38-2.5 to require prescribers to co-prescribe an opioid antidote (for example, naloxone) under certain circumstances. In addition, the Board proposes to amend N.J.A.C. 13:38-2.5 to implement P.L. 2017, c. 341, amending N.J.S.A. 24:21-15.2, which concerns limitations on the prescribing, administering, or dispensing of controlled dangerous substances, with specific limitations for opioid drugs, and establishes special requirements for the management of acute and chronic pain. The revised law and proposed amendments clarify the timing of the requirement to enter into a pain management agreement, amend the definition of “initial prescription,” and revise the definition of “chronic pain” consistent with the amended statute. Proposed Amendment: N.J.A.C. 13:38-2.5

 

  • On January 19, 2021, at 53 N.J.R. 114(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Physical Therapy proposes to readopt N.J.A.C. 13:39A with amendments, repeals, and new rules. Proposed Readoption with Amendments: N.J.A.C. 13:39A; Proposed Repeals and New Rules: N.J.A.C. 13:39A-5.5 and 5A; Proposed New Rules: N.J.A.C. 13:39A-4.3 and 5.2A.

 

  • On January 19, 2021, at 53 N.J.R. 124(c), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Medical Examiners adopted the amended rule requiring physicians to co-prescribe an opioid antidote under certain circumstances. Adopted Amendment: N.J.A.C. 13:35-7.6.

 

  • On January 19, 2021, at 53 N.J.R 137(a), the Department of Health published a public notice of petition for rulemaking for rule changes that permit the establishment of elective PCTA services with off-site cardiac surgery backup to be reviewed under the expedited CN review process and established rules for submission of CN applications for the provision of elective PCI at hospitals with off-site cardiac surgery back up. See N.J.A.C. 8:33E-2.17.
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